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PharmaCompass offers a list of Oxaprozin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Oxaprozin manufacturer or Oxaprozin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Oxaprozin manufacturer or Oxaprozin supplier.
PharmaCompass also assists you with knowing the Oxaprozin API Price utilized in the formulation of products. Oxaprozin API Price is not always fixed or binding as the Oxaprozin Price is obtained through a variety of data sources. The Oxaprozin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Oxaprozin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxaprozin, including repackagers and relabelers. The FDA regulates Oxaprozin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxaprozin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Oxaprozin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oxaprozin supplier is an individual or a company that provides Oxaprozin active pharmaceutical ingredient (API) or Oxaprozin finished formulations upon request. The Oxaprozin suppliers may include Oxaprozin API manufacturers, exporters, distributors and traders.
click here to find a list of Oxaprozin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oxaprozin DMF (Drug Master File) is a document detailing the whole manufacturing process of Oxaprozin active pharmaceutical ingredient (API) in detail. Different forms of Oxaprozin DMFs exist exist since differing nations have different regulations, such as Oxaprozin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oxaprozin DMF submitted to regulatory agencies in the US is known as a USDMF. Oxaprozin USDMF includes data on Oxaprozin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oxaprozin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Oxaprozin suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Oxaprozin Drug Master File in Japan (Oxaprozin JDMF) empowers Oxaprozin API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Oxaprozin JDMF during the approval evaluation for pharmaceutical products. At the time of Oxaprozin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Oxaprozin suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Oxaprozin Drug Master File in Korea (Oxaprozin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Oxaprozin. The MFDS reviews the Oxaprozin KDMF as part of the drug registration process and uses the information provided in the Oxaprozin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Oxaprozin KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Oxaprozin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Oxaprozin suppliers with KDMF on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Oxaprozin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Oxaprozin API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Oxaprozin as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Oxaprozin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Oxaprozin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Oxaprozin suppliers with NDC on PharmaCompass.
Oxaprozin Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Oxaprozin GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Oxaprozin GMP manufacturer or Oxaprozin GMP API supplier for your needs.
A Oxaprozin CoA (Certificate of Analysis) is a formal document that attests to Oxaprozin's compliance with Oxaprozin specifications and serves as a tool for batch-level quality control.
Oxaprozin CoA mostly includes findings from lab analyses of a specific batch. For each Oxaprozin CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Oxaprozin may be tested according to a variety of international standards, such as European Pharmacopoeia (Oxaprozin EP), Oxaprozin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Oxaprozin USP).